Project Mountain - Comparing SpO2 and SaO2 for Accuracy

• ClinicalTrials.gov Identifier: NCT06372106
• Recruitment Status: Not yet recruiting
• First Posted: April 17, 2024
• Last Update Posted: April 17, 2024
• Sponsor: Philips Clinical & Medical Affairs Global
• Information provided by (Responsible Party): Philips Clinical & Medical Affairs Global

Tracking Information

• First Submitted Date: March 29, 2024
• First Posted Date: April 17, 2024
• Last Update Posted Date: April 17, 2024
• Estimated Study Start Date: April 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 16, 2024)

To observed accuracy expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth. [ Time Frame: through study completion, an average of 8 months ]

The oximetry technology will be expressed in ARMS of SpO2 measurements obtained from neonatal, infant, and pediatric sensors with the Philips FAST Pulse Oximetry technology within the range of 70-100% in comparison to the SaO2 as ground truth.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: April 16, 2024)

• Secondary Endpoint -Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology. [ Time Frame: through study completion, an average of 8 months ]
  Non-disparate bias with consideration to skin pigmentation for each neonatal, infant, and pediatric SpO2 sensor under test with the Philips FAST Pulse Oximetry technology.
• Secondary Endpoint- Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation. [ Time Frame: through study completion, an average of 8 months ]
  Proportion of paired SaO2 and SpO2 readings in which occult hypoxemia (i.e., SaO2 <88% with SpO2 ≥92%) is identified among patients within the broad categories of light, medium, and dark pigmentation.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Project Mountain - Comparing SpO2 and SaO2 for Accuracy
• Official Title: Philips FAST picoSAT Convenience Sampling for Clinical Performance in Neonate, Infant, and Pediatric Patients
• Brief Summary: The main goal of this study is to look at the performance of the neonatal, infant, and pediatric Philips SpO2 sensors with the Philips FAST Pulse Oximetry technology. Oxygen saturation measurements (SpO2) will be obtained via pulse oximetry and invasive arterial oxygen measurements (SaO2) will be obtained via arterial blood samples as part of your clinical care and assessed by co-oximetry. The study will aim to enroll a diverse population to help us understand the impact of skin pigmentation.
• Detailed Description: This is a prospective, multi-center, multi-phase, unblinded, non-randomized. self-controlled, observational study. All data analyses specified below will be calculated and summarized by each of SpO2 sensors under test. Demographics and baseline characteristics, including sex assigned at birth, age, ethnicity, race, baseline height, baseline weight, BMI, skin pigmentation and sensor application site measurements will be summarized with descriptive statistics using the analysis set.
• Study Type: Observational
• Study Design: Observational Model: Other; Time Perspective: Other
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: The study will be conducted in neonate, infant, and pediatric patients admitted into an intensive care unit (e.g. NICU, PICU, PCICU).

Condition

• SpO2
• Nasal Alar Collapse, Bilateral
• Oxygen
• Measurement

Intervention

Device: SaO2 Sampling

CO-Oximetry analysis of arterial blood samples

Study Groups/Cohorts

• Neonates
  Even distribution of sex per skin pigmentation category (Light, Medium, Dark)
  Intervention: Device: SaO2 Sampling
• Infants
  Even distribution of sex per skin pigmentation category (Light, Medium, Dark)
  Intervention: Device: SaO2 Sampling
• Pediatrics
  Even distribution of sex per skin pigmentation category (Light, Medium, Dark)
  Intervention: Device: SaO2 Sampling

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 16, 2024): 560
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Subject aged 18 years or older or parent/legal guardian of subject aged less than 18 years, willing and able to understand and provide written informed consent/assent.
• Weight and/or age within intended use of at least one SpO2 sensor under test at time of enrollment.
• Willing and able to wear study devices in addition to SoC devices and during SoC procedures.
• In-patient within a neonatal or pediatric intensive care unit (e.g. NICU, PICU, PCICU).
• Has arterial access and ability to have arterial blood samples drawn as part of their SoC and analyzed by CO-Oximetry.

Exclusion Criteria:

• Known pregnancy or lactating females (self-reported)
• Injury, wounds, physical malformation, hyperkeratosis, or compromised/non-intact skin at sensor application site (i.e. fingers, toes, hands, feet, ears, nasal ala). Note: Certain malformations may be allowed if determined it would not affect application of sensor with the pulse oximetry system.
• Self-reported severe contact allergies to standard adhesives or other materials found in pulse oximetry sensors. Note: Subject may be considered eligible if subject can wear non-adhesive sensor.
• Unwillingness or inability to remove nail polish or artificial nails from sensor application site.
• Nail fungus on sensor application site.
• Wearing and unable to remove jewelry from sensor application site.
• Dye injection within 48 hours of enrollment.
• Known dysfunctional hemoglobin levels (COHb >3%, MetHb >2%, and ctHb <10g/dl)
• Undergoing phototherapy for neonatal hyperbilirubinemia during arterial blood sampling

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes

Contacts

Contact: Dhaval Patel; 508-907-2304; dhaval.patel@philips.com

• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT06372106
• Other Study ID Numbers: MA_PM_Mountain_2022_11496
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Philips Clinical & Medical Affairs Global
• Original Responsible Party: Same as current
• Current Study Sponsor: Philips Clinical & Medical Affairs Global
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Amira Azer; Philips Healthcare

• PRS Account: Philips Clinical & Medical Affairs Global
• Verification Date: April 2024